Identity
- Trade Name
- DERMLITE EUDAMEDDermLite DL5 Eyepiece FDA UDI
- Generic Name
- Dermatoscope, optical FDA UDI
- Device Name
- DermLite DL5 Eyepiece EUDAMEDMagnetic eyepiece for DL5 FDA UDI
- Model / Reference
- DL5-EP EUDAMEDFDA UDI
- Description
- Magnetic eyepiece for DL5 FDA UDI
Identifiers
- Catalog Number
- DL5-EP FDA UDI
- Primary DI / UDI-DI
- 08500176515008 EUDAMED00850017651500 FDA UDI
- Basic UDI-DI
- 0850017651500SK EUDAMED
- FDA Product Code
- KYT FDA UDI
- EMDN Code
- Z12040108 DERMATOSCOPES EUDAMED
- GMDN Term
- Dermatoscope, optical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6350 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dermlite by DermLite LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850017651500SK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DermLite LLC
- EUDAMED SRN
- US-MF-000005170
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (2)
- EUDAMED b59c7351-c218-4d04-af38-4e02dfd53ec6 61 fields · synced Jul 14, 2026
- FDA UDI cddb3b31-cc30-4feb-ade2-f419bf800b8d 35 fields · synced May 30, 2026